Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the three and nine months ended September 30, 2009.
“Our alliances have continued to achieve strong progress with Roche’s initiation of the Phase 3 registration trial for subcutaneous Herceptin, and Baxter’s completion of patient enrollment in the Phase 3 GAMMAGARD with PH20 pivotal study and the launch of Hylenex in pediatric hydration,” said Jonathan Lim, M.D., president and CEO. “Our balanced business strategy consisting of partnered development programs and proprietary pipeline product candidates made noteworthy advances through another quarter.”
Third Quarter 2009 and Recent Corporate Developments and Scientific Achievements
- Roche initiated a Phase 3 clinical trial with subcutaneous Herceptin formulated with Halozyme’s recombinant PH20 enzyme. This represents the first Roche product to enter a Phase 3 registration trial as part of the Halozyme-Roche collaboration, and initiation of this clinical trial triggered a milestone payment of $5 million to Halozyme. Roche intends to enroll 552 patients with HER2-positive breast cancer in the study.
- Roche also initiated a Phase 1 pharmacokinetic clinical trial with a subcutaneous formulation of a Roche biologic using Halozyme’s recombinant PH20 hyaluronidase enzyme. This biologic represents the third Roche proprietary compound directed to an exclusive target to enter the clinic as part of the Halozyme-Roche collaboration. Initiation of the study triggered a milestone payment to Halozyme for an undisclosed amount.
- Halozyme’s ultrafast insulin program moved forward during the third quarter. A Phase 1 clinical study began in September that will assess the effects of three approved prandial (mealtime) insulin analogs administered with PH20 compared to each of the analogs alone. This randomized, six-way cross-over design, euglycemic clamp study will compare the pharmacokinetics (PK) and glucodynamics (GD) of three insulin analogs. Previous studies conducted by Halozyme have demonstrated that the combination of insulin lispro (Humalog®) with PH20 yielded faster systemic insulin absorption, increased peak insulin concentrations, and improved glycemic control when compared to insulin lispro alone. The study is expected to enroll 18 healthy subjects and the results should be available by 2Q10. Our goal is to develop a best in class insulin product in comparison to the current gold standard analog products on the market today.
- Baxter, Halozyme’s licensee, launched Hylenex (hyaluronidase human injection) in early October at the scientific assembly of the American College of Emergency Physicians (ACEP) for use in pediatric rehydration. Hylenex allows fluids to be administered subcutaneously rather than through a vein, which can help lead to successful rehydration more quickly. Clinical data presented at the ACEP meeting showed that subcutaneous treatment facilitated by Hylenex successfully rehydrated 94% of pediatric patients, that 90% of catheters were successfully inserted on the first attempt, and 96% of clinicians rated the procedure easy to perform. Hylenex rehydration was preferred by parents as nine out of 10 surveyed were satisfied or very satisfied with the procedure.
Third Quarter 2009 Financial Results
The net loss for the third quarter of 2009 was $13.9 million, or $0.16 per share, compared with a net loss for the third quarter of 2008 of $10.9 million, or $0.14 per share. Net loss for the nine months ended September 30, 2009 was $45.7 million, or $0.54 per share, compared with a net loss of $31.8 million, or $0.40 per share for the comparable period last year.